Cavex ImpreSafe starterkit

Basic Information

• Brand Name: Cavex ImpreSafe starterkit
• Primary DI: E241HA0530
• Version / Model: HA053
• Catalog Number: HA053
• Company Name: Cavex Holland B.V.
• Labeler DUNS: 419980156
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-07
• Public Version: 3
• Public Version Date: 2020-07-07
• Public Version Status: Update
• Public Device Record Key: f29ff9c9-10a0-4933-8c6f-8f8dbc2391c3

Device Description

Dental impression disinfectant

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRJ	Disinfectant, Medical Devices	General Hospital	880.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35871	Denture cleanser	An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E241HA0530	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 pcs

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 25 Degrees Celsius